High strength balloon

ABSTRACT

A balloon catheter includes a balloon which is both of high strength and radiopaque. The balloon includes an outer strengthened layer which includes a strengthening element at least partially embedded within the layer. Concentrically within the strengthened layer there is a radiopaque layer which includes a high concentration of radiopaque material distributed in the radiopaque layer. The strengthened layer acts as a support to the radiopaque layer which is otherwise be unable to withstand the pressure to which the balloon is normally inflated for deployment and in the course of a medical procedure. The structure provides a high strength radiopaque balloon with a relatively thin balloon wall optimizing balloon flexibility and wrappability. There is also disclosed a method of making a balloon which uses an internal support layer in a raw tubing which is then removed following formation of a balloon.

CROSS REFERENCE RELATED APPLICATIONS

This application claims priority to U.S. Non-Provisional ApplicationSerial No. 13/784,028, filed Mar. 4, 2013, and titled “High StrengthBalloon”, the contents of which are incorporated herein by reference.This application also claims priority to GB application no. 1206541.3,filed Apr. 13, 2012, titled “High Strength Balloon,” the contents ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a balloon catheter for medicalapplications and in particular a high strength balloon which is readilyvisible under imaging.

BACKGROUND ART

Balloon catheters, in particular the balloons they carry, are used for avariety of medical applications including: delivery of implantablemedical devices such as stents and stent grafts, for vessel dilatation,angioplasty, valvuloplasty and so on. A number of these proceduresinvolves risk to the integrity of the balloon, which can tear or burstas a result of the stresses to which it is put and/or the pressure towhich the balloon is inflated. In addition, such balloons, which aretypically made from a polymer material for flexibility andcompressibility, are virtually invisible under imaging. Lack ofvisibility of the balloon causes difficulties in controlling thedeployment operation. To counter this, it is known to inflate medicalballoons with a contrast agent. This does not, however, resolve the lackof visibility of the balloon prior to its inflation. Moreover, contrastmedia is relatively viscous, leading to lengthened inflation anddeflation times, as well as not being particularly biocompatible andthus not ideal in situations where the balloon may burst.

While high strength balloons have been proposed, their structures can besuch as to add bulk and lose flexibility, which can lead to reducedwrappability and performance of the balloon.

Examples of prior art balloon catheters are disclosed in US2011/0160661, EP 0 768 097, U.S. Pat. No. 5,776,141, U.S. Pat. No.7,824,517 and US 2009/0306769.

DISCLOSURE OF THE INVENTION

The present invention seeks to provide an improved medical balloon andballoon catheter assembly, as well as an improved method ofmanufacturing a medical balloon and balloon catheter assembly.

According to an aspect of the present invention, there is provided aballoon catheter including a catheter having proximal and distal ends;and a balloon fixed at the distal end of the catheter, the balloonincluding a plurality of layers superimposed on one another, a first ofsaid layers being a strengthening layer and a second of said layersbeing a substantially radiopaque layer, the radiopaque layer beingpositioned inside the strengthening layer and being the innermostballoon layer. The radiopaque layer is advantageously unitary with thestrengthening layer.

This structure provides a high strength balloon which has the advantageof good visibility when deployed in a patient. Providing the radiopaquelayer internally of the balloon does not compromise the strength of theouter surface of the balloon, and moreover does not risk damage or lossof the radiopaque layer. The structure can also provide for a balloonhaving a minimal thickness wall, thereby enhancingcompressibility/wrappability and flexibility of the balloon.

Advantageously, the strengthening and radiopaque balloon layers areformed of or include a polymer material, preferably the same polymermaterial. This ensures that these two layers are coupled to one anotherin a unitary manner.

The radiopaque balloon layer may include a polymer mixed with powder,granules, pellets or fragments of radiopaque material. Preferably, theradiopaque material is or includes tungsten. It has been found thattungsten provides very good radiopacity in relatively small volumes.

Advantageously, the radiopaque balloon layer includes at least 50% byweight of tungsten powder. Embodiments may have 65% or 80% by weight oftungsten powder in the inner layer.

In the preferred embodiment, the strengthening layer includes at leastone strengthening element, advantageously being a strengthening sleeveformed of a mesh of filamentary or fibrous material.

The strengthening sleeve is at least partially embedded in a polymermaterial.

In the preferred embodiment, the strengthening layer forms the outermostlayer of the balloon and the balloon is formed of two layers. Thus, theballoon can have a relatively thin wall thickness, contributing toballoon flexibility and wrappability, yet be of high strength andradiopaque at the same time.

According to another aspect of the present invention, there is provideda method of manufacturing a balloon for a balloon catheter, the balloonincluding a plurality of layers superimposed on one another and havinginner and outer balloon surfaces, a first of said layers being astrengthening layer and a second of said layers being a substantiallyradiopaque layer, the radiopaque layer being positioned inside thestrengthening layer and forming the inner balloon layer; the methodincluding the steps of: providing a raw tubing including at least onelayer of a polymer material; providing a radiopaque layer inside thelayer of raw tubing; providing an expandable support concentricallyinside the radiopaque layer; inflating the raw tubing, radiopaque layerand expandable support in a mold so as to form said balloon; andremoving the expandable support from the produced balloon.

The method is thus able to produce the balloon in a single process. Theinner layer, when heavily radiopaque, is generally too weak to be ableto withstand inflation pressure, even during the process of manufactureof the balloon, that is the layer would tear of otherwise disintegrate.The provision of a removable support ensures reliable manufacturing ofthe balloon without adding to balloon thickness after formation of theballoon.

Preferably, the radiopaque layer is formed integrally with the rawtubing as a multi-layered tubing, for instance by being coextruded withthe layer of polymer material.

Advantageously, the method includes the step of providing astrengthening element to said layer of polymer material, thestrengthening element being provided in the mold and being attached,bonded to or embedded in the polymer layer on inflation of the rawtubing. Thus, the balloon can be provided with a specific strengtheningelement, incorporated at the same time as the manufacture by inflationof the balloon from the raw tubing. It is not necessary to apply thestrengthening element in a separate and subsequent manufacturing step.

Advantageously, the method includes the step of softening or melting thepolymer layer so as to cause the polymer layer to flow around thestrengthening element so as to embed at least partially thestrengthening element therewithin. The strengthening element can thus beincorporated into the balloon wall by what could be termed a reflowprocess.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention are described below, by way ofexample only, with reference to the accompanying drawings, in which:

FIG. 1 is a schematic representation of balloon catheter;

FIG. 2 is a cross sectional view of a first embodiment of balloonstructure taken along line A-A of FIG. 1;

FIG. 3 is a cross sectional view taken along line A-A of FIG. 1 of asecond embodiment of balloon structure;

FIG. 4 is an end view of the components used in the manufacture of aballoon having a structure of FIGS. 1 and 3; and

FIG. 5 is a schematic diagram of an example of mold for making a balloonas taught herein.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

It is to be understood that the drawings are schematic only and are notto scale. They are of a form which is intended to facilitate theunderstanding of the teachings herein.

Referring to FIG. 1, there is shown in a schematic form the principalcomponents of a balloon catheter assembly 10 which may include a balloon12 of the type disclosed herein. Catheter assembly 10 includes anelongate tubular catheter 14 having a proximal end 16 and a distal end18. The balloon 12 is fixed to the distal end 18 of the catheter 14,whereas the proximal end 16 of the catheter 14 is fixed to the handleportion 20, which in the example shown is a Y-connector provided with afirst port 22 for a guide wire (not shown) and a second port 24 for theadministration of inflation fluid to balloon 12. As is known in the art,catheter 14 includes at least two lumens therein, one coupled to theguide wire 22 and the other to the inflation port 24. The guide wirelumen extends all the way to the tip 26 of the catheter 14, allowing aguide wire to pass through the tip 26 as is known in the art. The lumenfor the inflation port 24 extends to an aperture or port (not shown) atthe distal end 18, specifically at the zone of the balloon 12 so as tosupply inflation fluid to the inside of balloon 12. Typical inflationfluid may be saline solution, a fluid including a contrast medium, as soon.

In FIG. 1 the balloon 12 is shown in an inflated condition, as it wouldbe used in the course of a medical procedure. This may be for thedeployment of an implantable medical device which is loadedconcentrically on the outside balloon 12, for vascular dilatation, forvalvuloplasty, for angioplasty and so on.

The balloon 12 is typically wrapped around the distal end 18 of thecatheter 14 for endoluminal delivery through a patient and in thisregard the assembly 10, apart from the fitting 20, will be containedwithin a carrier sheath of known type.

In accordance with the teachings herein, the balloon 12 is a highstrength balloon able to withstand higher pressures and greateroperating forces compared to equivalent balloons which are notstrengthened. Furthermore, the balloon 12 is substantially radiopaque soas to be visible during imaging of the patient in the course of themedical procedure. Yet, the preferred structures disclosed hereinprovide a balloon 12 of optimum wall thickness so as to retain balloonflexibility as well as good (tight) wrappability around the catheter 12in order to maintain a small diameter of the introducer assembly andthereby facilitating the deployment procedure.

FIGS. 2 and 3 show two embodiments of structure of the balloon 12 of theballoon catheter 10. It is to be understood that these drawings, as withthe other drawings of this application, are schematic only and not toscale. In many instances, the features in the drawings are shownenlarged or exaggerated in order to clarify the elements disclosedtherein. The skilled person will be readily aware of typical andsuitable dimensions for the balloon 12 and the components thereof. Forinstance, with respect to the embodiments of medical balloon 12according to the teachings herein, it is to be understood that FIGS. 2and 3 show structures of balloon walls which are many times thicker thanwould be used; in practice the layers will be very much thinner.Furthermore, the relative thicknesses of the layers of the balloon 12shown in embodiments of FIGS. 2 and 3 are not to scale and would differsignificantly in an actual balloon. The relative thicknesses of thelayers would be dependent upon the material used, the medicalapplication envisaged for the balloon and the arrangement of the variouscomponents of the balloon, amongst other factors which will be evidentto the person skilled in the art.

Referring first to FIG. 2, the embodiment of balloon 12 shown includesjust two layers, an outer strengthened layer 30 and an inner radiopaquelayer 32. The outer layer 30 is made of any suitable polymer materialincluding a polyamide such as nylon, a polyether block amide such aPEEBAX, polyurethane or any other suitable polymer, embedded within theouter layer 30 is a strengthening element 34, which in this embodimentis a strengthening sleeve formed of a mesh of fibrous material. Thesleeve 34 can be made of any suitable material including polymer, metalor metal alloy, natural fiber; one example being a polyamide such asnylon, ultra-high molecular weight polyethylene fiber such as Dyneema™,as well as graft or suture materials.

In a preferred embodiment, the strengthening sleeve 34 is a woven orknitted mesh of threads, in which the warp and weft fibers extend alongthe longitudinal and transverse axes of the balloon 12. Thestrengthening sleeve 34 can have other structures, including a coilextending helically along the balloon 12 or a punctured or aperturedsleeve of strengthening material, for instance.

The strengthening element 34 preferably extends along the entire lengthof the balloon 12, including the generally cylindrical body portion ofthe balloon and the conical portions either side of the main bodyportion, preferably up to the necks of the balloon which are attached tothe balloon catheter 14. The strengthening element 34 is of a naturethat it provides strengthening to the balloon 12 during inflation of theballoon 12, as well as during its medical use.

Internally of the layer 30 is the radiopaque layer 32, which ispreferably bonded or otherwise unitary with the strengthened layer 30.The radiopaque layer 32 preferably includes a high proportion of aradiopaque material therewithin. The radiopaque material may be in theform of powder, granules, pellets or fragments dispersed throughout thelayer 32. An embodiment provides tungsten powder at a concentration ofat least 50% by weight of the layer 32. Tungsten has been found toprovide very effective radiopacity even in relatively low amounts, aslong as there is sufficient concentration of tungsten. In this regard,other embodiments have greater concentrations of tungsten. Prototypeshave been produced with concentrations of tungsten of greater than 65%by weight, up to around 80% by weight.

The radiopaque material, as with layer 32, preferably extends along thewhole length of the balloon 12 but at least for the body portion ofballoon 12, more preferably along the body portion and the end coneportions and most preferably also along the necks of the balloon whichare bonded to the balloon catheter 14.

The remainder of the material forming the inner layer 32 is preferably apolymer material and most preferably the same polymer material as thatof the outer layer 30 or a polymer material which has an affinity withthe material of the outer layer 30 such that that the two layers 30, 32bind to one another in essentially a unitary manner. Use of the same orcompatible polymers for the inner and outer layers 30, 32 can create astructure in which the two layers are integral with one another and insome cases without any noticeable transition point between the twolayers. In other embodiments, where the materials of the inner and outerlayers 30, 32 do not naturally bond or integrate with one another, therecan be provided a layer of bonding agent which may be a polymermaterial.

The incorporation of radiopaque material within the inner layer 32,particularly in the form of powder, granules, pellets or fragments andparticularly at the concentrations envisaged herein, causes a weakeningof the layer 32 compared to a layer made purely of polymer material.More specifically, the embedding of the radiopaque material in the layer32, particularly in the preferred embodiments, results in the layer 32being unable to withstand the levels of fluid pressure to which theballoon 12 is subjected during its inflation and during its medical use.In other words, without the provision of a supporting layer such as alayer 30, the inner layer 32 would rupture if subjected to the normaloperating pressures of that balloon. It is the outer layer 30 whichsupports the inner layer 32 during inflation and use of the balloon 12,and which thus prevents the inner layer 32 from rupturing.

FIG. 2 shows the balloon 12 in its simplest and preferable form, that iswith just two layers 30, 32 forming the balloon wall. This can provide astructure with a minimal overall balloon wall thickness and therebywhich can optimize the flexibility of the balloon 12 as well as itswrappability onto the balloon catheter. It is, of course envisaged thatin some embodiments there may be provided additional layers to theballoon 12, for instance in dependence upon the nature of the layers 30,32 and the medical application intended for the balloon 12. Forinstance, as described above, there may be provided a bonding layer tobind the two layers 30 and 32 together, there may be provided atexturing layer outside of the layer 30, and so on. Some of theseadditional layers may add thickness to the overall balloon wall but inreturn for additional characteristics, features or functions to theballoon 12.

Referring now to FIG. 3, the embodiment of balloon 12′ shown in thisFigure is very similar to the embodiment of FIG. 2, save for the factthat the strengthening sleeve 34 is only partially embedded within thestrengthened layer 30. This may occur when the layer 30 is madeparticularly thin and thus not thick enough to embed the entirety depthof the strengthening sleeve 34 and/or in cases where it is deemedadvantageous to have the strengthening sleeve 34 partially exposed atthe outer surface of the balloon 12′. The latter may, for instance, beto provide texturing to the outer surface of the balloon.

Other than the position of the strengthening element 34, the embodiment30 of FIG. 3 is the same as the embodiment of FIG. 2.

Referring now to FIG. 4, there are shown the structural components usedin the formation of a balloon 12, 12′ of the type shown in FIGS. 2 and 3and as otherwise taught herein. The balloon is most usefully formed froma raw tubing 40 which in the preferred embodiment is a coextrusion offirst and second layers 42, 44. The first, outer, layer 42 is a layer ofpolymer material which eventually forms outer layer 30 of the balloon 12or 12′. Inner layer 44 is a layer incorporating radiopaque materialwhich eventually forms the inner layer 32 of the balloon 12, 12′. Theinner layer 48 visible in FIG. 4 is described below in connection withthe method of manufacture of the balloon for reasons which will becomeapparent.

With reference to FIG. 5, there is shown an example of the mold 50 usedfor manufacturing a balloon of the type taught herein. The structure ofthe mold 50 is not relevant to the disclosure in this patent applicationand can therefore take any of a known number of forms for such molds.Typically, the mold 50 will include a mold chamber 52 which is formed ofat least two parts which are separable in order to provide for theremoval of a balloon 12 made within the mold 50. The mold also includesinlets or openings 54, 56 designed to grip tightly a raw tubing 40during the heating and inflation steps of the molding process.

In the preferred embodiment, the balloon 12 or 12′ and indeed any otherballoon of the type contemplated herein, is preferably formed in asingle step process, in which the strengthening sleeve 34 is placedwithin the mold 50 prior to the inflation of the raw tubing 40.Specifically, the strengthening sleeve 34 is positioned within the moldchamber 52 prior to the insertion of a length of raw tubing 40. The rawtubing is held tightly at the inlet and outlet ports 54, 56 and the endof the tubing 40 at the outlet 54 sealed closed. The mold is then heatedand inflation pressure fed into the lumen 46 of the raw tubing 40, thiscausing the raw tubing 40 to expand radially outwardly.

The raw tubing 40 is heated to a temperature sufficient to cause theouter layer 32 to soften or melt. Thus, as the raw tubing 40 expandsunder the inflation pressure towards the walls of the chamber 52 of themold 50, the strengthening sleeve 34 will become embedded, at leastpartially, within the material 42 and thereby eventually within theouter layer 30 of the subsequently formed balloon.

It will be appreciated that the inner layer 44 of the raw tubing 40 willlikewise expand and act to press the outer layer 42 radially outwardlyas the result of inflation pressure within the lumen 46. Thus, by asingle manufacturing process, the balloon 12 can be formed within themold 50, in contrast to methods which require subsequent manufacture andassembly steps to form multiple layers and specifically also to attachfurther components to the formed balloon.

When the concentration of radiopaque material within the layer 44 of theraw tubing 40 is particularly high, it has been found that in somecircumstances the inner layer 44 of the raw tubing 40 can fail to expandreliably, leading to the creation of a degraded inner layer 32 to theballoon 12 or 12′. For this purpose, in the preferred embodiment theremay be provided an additional layer 48 to the raw tubing 40, this beingan innermost layer of the tubing. The layer 48 is used solely during themanufacturing process of the balloon 12, 12′ and is removed from withinthe balloon after the formation thereof. For this purpose, the innerlayer 48 may be formed of a material which does not adhere or bond tothe radiopaque layer 44, a suitable material being PET.

The internal layer 48 of raw tubing 40 thus acts as a support to theradiopaque layer 44 to ensure the latter remains integral and consistentduring the heating and inflation process, thereby to form a uniform andstable internal layer 32 to the balloon, 12′. Once the balloon 12 hasbeen produced, as a result of the lack of adhesion or binding of theinternal layer 48 to the material forming the radiopaque layer 32, thelayer 48 can simply be peeled off the internal surface of the balloon,plus leaving the radiopaque layer 32 as the innermost layer of theballoon. Once formed, the inner radiopaque layer 32 does not need anyfurther support as it will be supported in effect from the outside in bythe strengthened layer 30. Thus, a radiopaque high strength balloon canbe produced with minimal wall thickness.

It is to be understood that although tungsten has been described as apreferred radiopaque material, other radiopaque materials may be usedincluding gold, silver, carbon and platinum. A combination may be used.

It is to be understood that the features of the different embodimentsdescribed can be combined with one another and that the claims are to beinterpreted, even though initially set out in single dependent form, asbeing combinable as if in multiple dependent form.

What is claimed is:
 1. A method of manufacturing a balloon for a ballooncatheter, the balloon including a plurality of layers superimposed onone another and having inner and outer balloon surfaces, a first of saidlayers being a strengthening layer and a second of said layers being asubstantially radiopaque layer, the radiopaque layer being positionedinside the strengthening layer; the method including the steps of:providing a raw tubing including at least one layer of a polymermaterial, providing a radiopaque layer inside the layer of raw tubing,the radiopaque layer being the innermost layer of the raw tubing,providing an expandable support concentrically inside the radiopaquelayer, inflating the raw tubing, radiopaque layer and expandable supportin a mold so as to form said balloon, the balloon being formed on aninterior surface of the mold, and removing the expandable support fromthe produced balloon.
 2. A method according to claim 1, wherein theradiopaque layer and the strengthening layer are formed together as aunitary layer.
 3. A method according to claim 1, wherein the radiopaquelayer is formed integrally with the raw tubing as a multi-layered tubingwherein the radiopaque layer and the raw tubing are in contact with eachother.
 4. A method according to claim 1, wherein the radiopaque layer iscoextruded with the layer of polymer material.
 5. A method according toclaim 1, including the step of providing a strengthening element to saidlayer of polymer material, said strengthening element being provided inthe mold and being attached, bonded to or embedded in the polymer layeron inflation of the raw tubing.
 6. A method according to claim 5,including the step of softening or melting the polymer layer so as tocause the polymer layer to flow around the strengthening element so asto embed at least partially the strengthening element therewithin.